Showing posts with label gene patents. Show all posts
Showing posts with label gene patents. Show all posts

Wednesday, June 19, 2013

Philosophy and Public Policy: Metaphysics Matters!

It has been nearly a week now since I received word about the outcome of the Myriad case. I was travelling at the time and suddenly started getting congratualtory emails and Facebook messages, so I went online via free wifi at the coffee shop I was at in the US, and quickly found the news that the Supreme Court had unanimously rejected Myriad's arguments. I was so excited I hit my best friend in the chest... sorry Justin. Now that a week has passed, and the airwaves and blogosphere have been awash with a plethora of incriminations, congratulations, and musings about what it all means, I want to address what is to me a central lesson: philosophy matters.

Sure, some will claim this decision was a legal one, having no relation to philosophy, but such claims betray a complete ignorance about what philosophy is. My book and the writing and speaking I have done on the subject of gene patents ever since have focused upon the ontology of the underlying objects. I have long felt that before we can approach ethical questions we need to clarifying what we are dealing with. I did this first for software, then genes, then nanotehnology. While I have taught medical and bio-ethics, the thesis of Who Owns You is not guided by standard bioethical principles, but rather founded upon uncovering the nature of the objects involved in the debate. Thus, my arguments about the nature of the "commons-by-necessity" and the status of genes as part of that commons confused some who expected typical applied ethics arguments, or legal anti-commons claims. For the past four years, what I have tried to do is show by recourse to basic ontological concepts, that unmodified but merely isolated genes are not different in kind from the genes claimed by Myriad and others as found in nature.

In the course of these arguments, the illogic of those who pursued the course of maintaining gene patents as they existed was laid bare, perhaps never more clearly than in debates about the nature of another naturally-occurring product: O2. When it became clear through those arguments that patent attorneys and others who supported gene patenting must also endorse patenting O2, the necessity of ontology was also revealed. Despite their claims otherwise, a world in which individual O2 molecules are distinguished from each other based upon their origins makes little sense ontologically, forget the ethics. One needs to confuse process with product, a basic ontological error, to support such a view. The Supreme Court, whether they realized it or not, sided with sound ontology. Although lacking the language that philosphers use when engaging in ontology, the Supreme Court's opinion makes both logical and ontological sense.

The Court has reasoned that the BRCA mutations claimed in Myriad's patents, even though "isolated" from the surrounding genome, remain "natural phenomena." An explanation for how this is so resides in ontology. In each case, the molecules described by the nucleotide sequences identified are not the result of man's design. They are nature's own products. Similarly, even when synthesized, O2 is never the product of man's design.  The process of creating isolated BRCA mutations in the lab may well be man-made, but will never result in anything other than a natural product because the product is one designed by evolution, not human ingenuity. We could call lab-made O2 or BRCA genes "synthetic natural products," and explain this by understanding that the process of making something cannot be confused with the resulting product. To be non-natural, both the intention of creating the product and the design of the product must come from minds. This is why I am more or less comfortable with the court's holding that cDNA is patent-eligible, because in producing cDNA (when, as the Court notes it does not exactly mirror sequences found in nature), one must combine intention with design.

At one of my recent talks, someone asked why in making my arguments I relied on ontology rather than ethics. My response was that courts are typically unmoved by ethics. This may be suprising, but it is true. The Court's decision in Myriad is about the nature of the underlying objects, not about what is right or wrong. Perhaps there is an ethical dimension to the general prohibition against patenting abstract ideas, natural phenomena, and laws of nature. Or perhaps not. Perhaps this restriction is about the nature of the objects too, as I have claimed when I argue they are simply materially and logically (and thus maybe also ethically) "unencloseable." But the Court's decision is guided, whether knowingly or not, but an ontology, and one which is coherent if understood as I am describing it. It provides guidance for those who conduct basic research, and those who wish to commercialize inventions. It offers some clarity where the law had deviated from logic. It illustrates that philosophy is not divorced from other subjects, and can indeed be relevant in numerous spheres. Indeed, metaphysics matters a great deal, and we engage in its practice every day to greater or lesser degrees, and sometimes public policy is significantly affected by its improper or proper uses. Philosophers would do well to point out the role of philosophy, as illustrated by the Myriad case and its implications, in the real world, and those who fail to see this as an implementation of philosophical reasoning should review the role and nature of philosophy historically. It really is the meta-science.

Friday, June 14, 2013

looking back and preserving history

Strangely, in the wake of the recent Supreme Court decision in Myriad, one of my very my very first public posts on the subject of gene patents, made at the invitation of Gene Quinn at ipwatchdog.com, seems to have disappeared from his archives. Meanwhile, he is claiming as others have done that my original statements and arguments went far beyond what the Supreme Court did. In the interests of preserving history, I'm reposting my article so you can judge for yourself the extent to which the Court has essentially restated my arguments. I believe they have.
"
The Case Against Gene Patents
Written by David Koepsell
Posted: June 13, 2009 @ 5:35 pm
I favor innovation, and am interested in ensuring that science and
technology work hand in hand to both better our standard of living, and enrich those who create new and useful works. But it is not necessarily true that current intellectual property laws always accomplish this. Nor is it so that everything under the sun is subject to intellectual property protection. When Jonas Salk developed his vaccine for polio, he was asked by Edward R. Murrow who owned the patent on the vaccine. His famous reply was "well, the people, I would say. There is no patent. Could you patent the sun?"

Since the mid 1990s, patents have been granted for human genes. Although now they are supposedly limited only to "isolated and purified" genes, this is a limitation of no consequence at all. It merely means marking the beginning and end point of the gene, and perhaps leaving out a few introns (which are meaningless junk that doesn't do anything to the functioning of the genes, and that remains as a byproduct of evolution." I argue that this is as ""inventive" as marking the boudaries of natural features, like mountains, on a map. It gives the mapmaker no right to the mountain, nor to preclude others from depicting that mountain.

The practice of patenting genes began during the progress of the Human Genome Project, which was a world-wide publicly funded scientific endeavor to map the human genome. While the HGP released the data it found into the public domain, it left open the option of "downstream" patents for new, inventive innovations, treatments, etc., that might come from the research. Meanwhile, Celera began to patent an unspecified number of sequences it found in its private attempt to map the genome. It's "shotgun" approach to sequencing remains a vital, patentable innovation that has changed the way gene sequencing is done. It was new, inventive, useful, and non-obvious. But this is not true of human genes
that are being patented.

The first public altercations over gene patents came from groups
representing those who suffer from genetic diseases. Canavan's Disease is a monogenic disease (it is carried by one gene only) that strikes a disproportionately among people of Ashkenazi Jewish heritage. When Miami Children's Hospital acquired a patent for the gene, a group representing families suffering from Canavan's Disease sued under tort law. They claimed that based on the patent, he Miami Children's Hospital was unjustly enriched when they not only collected royalties but restricted the number of labs that could offer testing for the disease and charged a fee beyond the cost of the test. Because of the restrictive licensing, many labs stopped offering the test. The case settled, and the legality of gene patenting remains unchallenged in court. It has so far been
based only upon the PTO's interpretation of regulations it has promulgated. Recently, the ACLU's suit against Myriad over its tests for the "breast cancer genes" has brought this issue back to the spotlight.

I argue in my book - Who Owns You? - that gene patents violate the patent law because what they claim as patentable is a part of nature, and thus neither new nor non-obvious. Awarding patents to non-new discoveries does not encourage innovation, and sitting on what are essentially laws of nature, so far upstream, actually stifles downstream innovation. Moreover, There are certain things that we have regarded both culturally and legally as belonging to a commons, and thus not subject to private ownership. I argue that unmodified genes are exactly
this sort of thing.

In Gottschalk v. Benson, the Supreme Court stated: "the patent would
wholly pre-empt the mathematical formula and in practical effect would be a patent on the algorithm itself." That would amount to patenting an abstract idea, contrary to long established precedent. Laws of nature are inherent in nature. We do not invent them, they are part of the fabric of everything. Gravity is an example, the laws of evolution are another, as are the laws of relativity. Scientists devise explanations for these laws that we call "theories", and attempt to confirm or falsify them through experiment. As we acquire a better understanding of natural processes and products, we become better equipped to manipulate our world, create new things that nature never made, and bring our inventiveness to bear on nature to make our lives better. This is, in sum, the purpose of intellectual property law: to further the progress of the useful arts and sciences. But if we try to do so by allowing governmentally-sponsored monopolies (as intellectual property ultimately is not a free-market device) we must be careful to not stifle innovation by granting monopolistic rights over laws of nature. Instead, we should grant rights only to those things that are the products of human thought
and creativity. The application, for instance, of the laws of gravity to some specific way of moving people up and down between floors. The splicing of a genetic segment into a creature in such a way that nature never devised to make an entirely new creature that might, for instance, eat oil, is inventive. Finding a gene that has evolved over millenia is not.

Finally, I argue that the genome is a commons. There are parts of the world that cannot be owned in any practical sense. Radio spectra are my favorite example. There's no way to exert ownership over a particular band. I can exert my ownership over my possessions and my land, but the only means of trying to control a band on the radio spectrum is to broadcast over it. But along comes my neighbor who does the same thing, and cranks up the wattage. There is no winner. It is the classic tragedy of the commons. I argue that genes, which are, after all, parts of what Richard Dawkins calls "the river of life flowing out of Eden" are simply unencloseable. Parents all over the world are reproducing patented genes, technically violating the patents on those genes because they
haven't sought permission and aren't paying royalties. The idea is absurd, of course. This is why the practice is absurd. Unmodified genes simply cannot be owned, nor should they be. 

But there's plenty of room for innovation. As I mentioned, Celera deserves the fruits of its invention in developing new, useful, non-obvious technologies for rapidly sequencing genes. When new methods of testing are developed, they ought to be rewarded. A number of corporations agree with the thesis that patenting too far upstream actually stifles innovation, and the SNP (single nucleotide polymorphisms) Consortium is a prime example. The Consortium itself is a not-for-profit organization made up of the Wellcome Trust, a number of
leading academic centers, and thirteen pharmaceutical and technological companies. These members have joined efforts to discover the roughly 300,000 SNPs thought to exist in the human genome, and to release this information into the public domain, while securing for each member IP rights over real innovations developed both along the way, and as a result of the effort. The same is true of the HapMap project which includes private companies, academic centers, and public and private research institutes. These efforts underscore the role of public science in profitable enterprise, and the recognition by corporations of the role of each in spurring innovation. None of the private corporations involved in these efforts could be accused of being wild-eyed anarchists seeking to undo private property rights. They simply realize that not everything should be patented, and that upstream patents can stifle downstream innovation, slowing the progress of the useful arts and sciences, and undermining the purposes for which patents were invented in the first place.

My book is certain to cause disagreements, as there is room for reasonable people to debate my assumptions about the role of intellectual property in innovation, as well as the nature of genes and genomes. But this is an issue that requires public debate, and legal challenge. Whether the courts or legislators ultimately change the way that genes are now being patented remains up in the air, which is why now is a perfect time to decide for yourself, and make your arguments, and be heard on this vital issue."

About the Author
David Koepsell is an author, philosopher, and attorney whose recent
research focuses on the nexus of science, technology, ethics and public
policy. He is an Assistant Professor at the Delft University of
Technology, Faculty of Technology, Policy, and Management, Philosophy
Section, and he blogs at Who Owns You?

Tuesday, October 2, 2012

In the Meantime...

I decided while we wait for things to happen in the Myriad appeal to post the selection below, a Foreword I wrote for the upcoming book A Question Mark Above the Sun by Kent Johnson, to be released in the next few weeks by Starcherone Books. Because the question of "creation" is vital to my argument about rights of inventors over sequences they didn't write, but merely found and copied, I thought readers of this blog might see the nexus between authorship, creativity, and ownership in other media. I loved writing this, and hope you'll enjoy, and I urge you to support Kent Johnson by buying his book, because it's great:


-->
A Question of Authorship?
David Koepsell

The relations between authors and texts are as complicated as any human relationships – perhaps even more so. Who counts as an author, and what connects the author and a text once written are much debated, and long have been. Academic arguments, for instance, about the “true” author of Shakespeare’s work rage still, many hundreds of years after the canon was written. Arguments in academia often focus about who counts as an author, and who should be so named on journal articles. Credit for authorship is a much older, established right for which duties might be owed than, for instance, the relatively modern institution of copyright. But the connection between author and work has always been tentative, and theories of literary criticism have wavered between those who insist upon authorship’s critical importance and others who maintain the absolute irrelevance of questions of authorship or author’s intention. Simply put: should we care who wrote something, really? Does it ultimately matter? And to what extent are authors really responsible for a text, or owed some duty of attribution? Finally, are “errors” of attribution harmful? These are deeply philosophical questions of ethical import raised intriguingly in the following pages by Kent Johnson. But before we get to “his” text, I’d like to address the fundamental, metaphysical and ethical issues underlying both his work and the controversy around which it dances so eloquently.

For almost two decades now I have turned my attention to the metaphysics of expressions. Specifically, I have been interested in what counts as an expression, and how expressions differ from other sorts of things. In that time I have mostly concentrated upon the legal category we call “intellectual property,” which most of us know as copyrights, patents, and trademarks. In the course of this work I’ve come to a theory of expression that has implications broader than IP law, which concerns legal monopolies to profit from expressions. My work has led me to critique the foundations of IP law for various reasons that are not relevant to this text. But the broader implication of what I have come to believe is, namely: expressions, once expressed, do not belong to the author. To get to this point, and its obvious implications for the remarkable events behind A Question Mark Above the Sun, let’s look at what it means to be an author, and what an expression is, stripped down to their elemental forms, and without worrying for the moment about what we think ought to be the case.

An expression is the extension of some idea into the “real” world. Ideas exist as thoughts in minds until they are expressed, and then they take on lives of their own. In fact, this is why modern intellectual property (IP) laws were created: because once an expression “leaves” the author, it is simply no longer physically (and maybe morally) beyond the realm of his or her dominion. The expression is free for all to adopt, appropriate, alter, or re-express. So we should be skeptical of claims about any “exact” connection between an author and an expression. This is certainly true for expressions that have been around a long time. The works of Homer, for instance. Homer’s works were recited for ages before they were written down as poems and songs that were part of an oral tradition that predated modern, mass-produced copies of either. Whose expression is “The Illiad”? even assuming a largely mythical Homer did exist, “his” epic poetry was told and re-told many thousands of times, doubtless changing over time, with new riffs and tweaks added by balladeers over the ages before someone first published a written copy, or before a standard Homeric canon was created some centuries later. Then translated, the meanings and nuances added or lost are the result of the translators. Whose voice remains? Is it Homer?

Of course Homer’s works are no longer truly Homer’s, and may never have been. In a very real sense, they ceased to be Homer’s (or the author(s)?) once released into the wild. There they took on new forms, and their current iteration, while still attributed to some author we call “Homer” (or someone, the joke goes, not Homer but with the same name) is a text whose authorship is very much literally doubtful. It is the work of legions, now, unnamed and unimportant in the grand scale of literature. Works such as Homer’s, like the Bible, for example, historically remote and oft-changed, altered and translated over millennia, are most clearly distinct from the expressions of their “original” authors. These sorts of works raise not just metaphysical, but ethical questions about the role and importance of authorship to a particular text. Does it matter, for instance, if Homer did not write, originally some particular verse or phrase, or for that matter, Homer’s works in their entirety? Is there some right or duty relating to the first expression of some idea, and its ultimate fortune?

While we may be responsible for our expressions when they are made, the root of that responsibility is in the choice of making the expression and in its initial content. It is a terrible risk to express an idea, one imbued with more chance of failure, ridicule, and numerous other potential liabilities than with “success.” Success generally means finding an audience that appreciates or at least acknowledges the expression. Most expressions drift away into the winds, never to be remembered. This is often thought of as the worst sort of failure for an author. But is this sort of failure linked to the fate of the expression, or the fate of the expression’s linkage to the author? The answer to this, which is in many ways the question underlying Kent Johnson’s musings and research, depends on what is important to the author as much as what is appreciated by an audience. What if there is no one “Homer” or what if Shakespeare either didn’t write some or all of Shakespeare’s works? What does this mean for us, as an audience, the worth of the works, and the value of Homer or Shakespeare as poets?

Most authors want to be connected to their works. Their expressions are personal, and this is the great risk of authorship. The courage to express means also accepting the great risks of expressing. Oblivion, ridicule, criticism, and obscurity are one’s most likely fates, but all authors dream of making some lasting impact on the world through their expression in some medium. Sculptors and architects do so with real, lasting monuments, and those who write attempt to do so with materials more ephemeral. Balladeers’ and dancers’ mediums of expressing are more fleeting still. Some people believe that taking the risk of expressing an idea in some medium requires that the community of potential observers and appreciators acknowledge that risk through such things as attribution and more recently, monopolies. Some authors (and clearly, I am using this term very loosely because I view expressions as occurring in many types of media, at the hands of a range of artists and even inventors) choose to produce their expressions anonymously, or care little for their attribution. Their reasons may be many and varied. Perhaps they fear the potential risks, or maybe they see the expression itself as being more important than attribution.

The question for us, if we are concerned with the ethics involved in “proper” attribution, is: is attribution of expression to author a moral requirement? Improper attribution can be a moral wrong where an expression is harmful, somehow. Attributing a libelous expression falsely is clearly wrong, as it passes off a responsibility for harm to an innocent party. Attribution, or the naming of the original author, is not only often imprecise (because as we saw above, expressions are changed over time, and may accumulate numerous authors) but is not morally required. Authors might wish to be associated with their expressions, but we are under no positive duty to ensure they are.

Part of the risk of expression is that the thing expressed lives a life of its own, flitting off into the wild, morphing over time, affecting audiences in any number of unpredictable and unintended ways. An author could no more ethically take credit for unintended good effects than for unintended bad ones. Once “free” of the author (once expressed) the expression and author are related only tangentially, as a perhaps interesting story about a particular expression’s origin, but little more. Our expressions live on, populating the world, replicating, thriving without us, and we should be glad of this. Just as with children, for whom we might be proud as they grow, thrive, develop, and go about their lives; our expressions live on, thrive, die, or remain unknown despite our hedonistic wishes for immortality. Children are not their parents, and their successes or failures speak only partially to our success or failure as parents. Authors and parents want to claim credit for the successes of their expressions or children, but allowing them to succeed (or fail) without the necessity of taking that credit represents a greater moral choice.

In fact, this is the realization of much modern literary criticism and its disentangling of author, intention, and expression. The work speaks for itself, and while we might very much enjoy trying to discern the author’s intention, doing so is epistemologically impossible, perhaps even for the author at the time of expressing. Kent Johnson takes this to its logical and moral extreme, questioning the rights, duties, and nature of authorship and attribution in general. He does so from firm ground. Authors have long toyed with the nature of their own authorship, and created personae and pseudonyms to make their expressions on their behalf, implicitly acknowledging the absurdity of any firm connection between expression and author. Araki Yasusda, who may or may not have been a Japanese poet whom Johnson translated, is but one example, and the story Johnson weaves to make his political and moral case about “O’Hara’s” poem is both serious philosophical inquiry and wrenching satire.

Modern political economy and the nature of profits in the publishing world have encouraged adopting a myth about the relation of author to work. This myth, destroyed effectively by Johnson, and undermined by the historical examples I have noted above, is that expressions are the author’s and that we must somehow acknowledge their conception to them and their profits. We choose to do so now for complex reasons, and in so doing may very well undermine the moral worth of creative expression. Blockbuster authors are now often industries around which publishing empires rise and fall. For instance, Bloomsbury, which published one of my books, has made a fortune and grown significantly propelled by the profits of Harry Potter. J.K Rowling is now inextricably associated with the Harry Potter volumes and movies. Rowling is as much a brand as the books themselves, expertly crafting a persona and canon that will, for the foreseeable future be known both as her and hers. How does Harry Potter stack up to Beowulf?

I’ll take a great risk and suggest that in the next thousand years or so, if humans remain, and English is still read, Beowulf will continue to have an important role in our culture and Harry Potter will not. J.K. Rowling may well be regarded as a successful author in her time, and Harry Potter valued for introducing a generation of kids to long-form fiction reading, but as great literature whose impact on a culture is historically important and meaningful, Beowulf, whose author is unknown, is a monument unlike most modern works. Were I the author of Beowulf, if indeed there was a single author, I’d prefer that sort of legacy to Rowling’s. While works of greatness uncoupled with fame or fortune do not pay the bills, they are the reason most good authors take the risk of authorship to begin with. But there are few truly good authors, and fame and fortune are the current gods to which we worship. Now here comes the proselytizing, and forgive me, I am not primarily a fiction author (though I have dabbled). Authors should strive neither for fame nor profit. Thus, attribution ought not to be an author’s primary concern (or even a concern at all), but rather the expression itself ought to be an end in itself, rather than a means to some other end. The author’s primary duty overrides claims of obligations owed by others, beyond the duty not to falsely attribute. If the author’s duty not to claim rights to expressions is true, as I claim it is, then there is no harm in even false attribution where there’s no harm. Yes, some artists want to be known for their works, but more often than not, true artists want their works to be known.

Consider Banksy. Banksy is famous for his works, iconoclastic stencils that began as graffiti, but are known and sought the world over as art. But Banksy is a pseudonym, and the ongoing power of his work stems in part from his carefully crafted and preserved anonymity. In the film Exit Through the Gift Shop, we see Banksy’s hooded figure, and marvel at the rise of an obsessive-compulsive documentarian of graffiti art’s own rise to the heights of artistic success, trading on the modus operandi of Banksy, but without so much talent. Of course the joke may well be on us, as the whole “documentary” seems ultimately to have been a charade of sorts, making fun of the art world, fame, glory, money, and the role and importance of critics in turning the previously banal into gold. This film, like Orson Welles’ F For Fake, uncovers the ludicrous extent to which we attach names and histories to expressions, and how this turns something into a treasured piece of “art.” Welles’ “film essay” (as he called it) itself plays with notions of authenticity and authorship, focusing on famous fakers such as Elmyr de Hory, one of the twentieth century’s most successful art forgers. News that many of the forgeries that de Hory had sold ended up in famous galleries throughout the world both enraged collectors and urged them to be silent. So many “authentic” Matisse’s and Picasso’s, all suddenly called to question. The value of each as a market commodity must now be forever in doubt, even if the artistic value of any of them might be unscathed.

What is it after all that makes a particular Vermeer valuable? Han van Meegeren, who faked and forged dozens of Vermeers, sold them successfully to educated collectors and museums before he was caught. Was it the signature that made the painting a worthy piece of art? Was it the art itself? Orson Welles’ great works were fakes of a kind as well, under the guise of which he could more successfully treat delicate subject matters, like the story of William Randolph Hearst under the very thin guise of Citizen Kane. Clifford Irving, who wrote the book Fake! About de Hory, became Welles’ subject in F for Fake when his attempt to publish an official “biography” of Howard Hughes becomes exposed as a fraud. And around and around we go. Author, work, truth, fake, art, critic… the lines are forever blurred when we begin to grapple with the metaphysical natures of each, and the ethical duties of author and audience.

Johnson upends and dispels all the traditional notions of authorship and its role in creation, scandalizing many in the process. This is what happens when the status quo, by which the current business of publishing continues and profits some, is challenged at its very base. It is a final deconstruction, of sorts, to claim as he does through the thin veneer of fiction, that there is some sort of conspiracy at work protecting the origin of a great poem. There is a conspiracy at work. There are several, in fact, including the twin conspiracies of convention and commerce, according to which authors are the inventors of the works they create and, like Thomas Edison, should profit through a state-supported monopoly over their “creations,” as well as some social-institutional monopoly over its essence. To pretend there is some sort of strict tie, some ownership, some moral right to protect and defend an expression once expressed is a form of authorial authoritarianism. It is the antithesis of free thought. Ideas don’t want to be free, they just are. Part of the risk of expression involves the loss of control.

But authors who aspire to Homer’s fate take that risk and launch their works into the winds and hope. Hope is the thing with feathers, and great works take flight without legal institutions, critics, or conventions to buoy or defend them against history. The freedom of expression is perhaps our most basic right, because it intercedes at the barrier between the mind and the body, where we choose to bring ideas into the world, but it comes with a certain responsibility too. “Our” ideas are only genuinely ours to the extent that we keep them trapped in our minds, and even so, they are likely not just ours. More often than not, they come from somewhere and someone else. Great ideas turn up historically in numerous places at once. Newton, who (may or may not have actually) said he stood on the shoulders of giants, quarreled with Leibniz for years about the origins of calculus. Their approaches to the problems of calculus were different, but solved the same problems using differing methods. Today, both Leibniz and Newton are celebrated, and calculus (whoever “created” it) helps propel rockets to the planets and beyond. Newton, and Leibniz, and every other scientist before and since has stood on the shoulders of giants: their peers, and their betters, who preceded them. Science is an evolving narrative, constantly refined but never perfected, a cycle of observation, hypothesis, synthesis, theory, observation, falsification, hypothesis, and so on.

Literature too is an evolving system, a dialogue of sorts among authors and voices within a tradition (sometimes encompassing numerous languages) over time. Ulysses is Joyce’s homage to the epic, borrowing from and imitating various styles, merging fiction, politics, religion, and culture in a new tapestry, the parts of which are neither new nor original. Ulysses is Odysseus, and Joyce plays Homer, wrapping an ordinary Dublin day in the cloak of epic. It was scandalous too, for different reasons, daring to elevate the bodily and the base, and insert them into epic. Since its original publication, Ulysses has changed, and the version that many of us grew up with as the “official” version has been replaced by a work alleged to be more closely aligned with Joyce’s own intention. Are there two Ulysses? Which is the real one? And who wrote each? Ulysses evolves, even as the Homeric epics have. Like all expressions, it is susceptible to revision and change, and Joyce’s intentions are both unknowable and irrelevant. Only a certain cult-like adherence to the myth of some strong link remaining between author and expression will defy this inevitable tendency. To defy this is to deny the true status of expression and to insist on some morbid, unnatural stasis in our culture and its artifacts.

And so what if? What if Johnson’s story is “true” to the extent that Koch wrote O’Hara’s haunting, prescient poem as an homage, an act of beneficence, the selfless act of an author who recognizes the overarching duty to express free of any egotistical desire for attribution? Is positing such an act of friendship, honor, and beauty a crime? Is it even just ethically wrong or suspect? I think it’s a lovely idea, and Johnson takes the risk as any author does of expressing his idea in a creative way. In so doing, he enriches the culture with literature, raises important philosophical questions, as is his wont, about the nature, duty, and obligations of authorship, and provokes further inquiry and wonder about a literary moment. It is interesting to ponder. It would be, as Johnson suggests, a truly supererogatory act if true. It is useful to consider the nature of acts through fiction and non-fiction. Ethicists do this all the time. We posit trains, and multiple tracks, and sacrificing 1 person versus 5, we compose outrageous hypothetical situations so that we can consider the ethical issues at play. These narratives are sometimes ridiculous and disturbing (as in the various “trolley” examples, involving choices between killing numbers and types of bystanders who happen to be stuck on railroad tracks) and even scandalous (cannibalism on lifeboats, etc.). But these stories are meant to provide insight into values by forcing us to consider what roles intentions and consequences mean for ethical decision-making.
Philosophers exchange, comment upon, revise, and embellish hypothetical examples used in ethics research. The history of philosophy in general, as in all scientific research, is a history of footnotes, critique, and revision of ideas whose geneses are often now obscure – standing on the shoulders of giants. Claims of originality must be looked at skeptically.
 
Johnson crafts a fictional account (a hypothesis of sorts) as a means of inquiry, as scientists do, as philosophers do, to examine a possibility. Like good science fiction and good science as well, it is founded upon entirely plausible circumstances, with some interesting and unlikely drama thrown into the mix from literary license. Like good literature, it launches itself as an expression into the winds of history and opens itself up for our use as we see fit. The laws these days still allow this sort of supposition, though we should be mindful about trends that could silence it. Laws are constantly refined to benefit the monopolists of expressions. Science itself is becoming monopolized by desperate academic presses intent on placing profit over the ethos of science, which has hitherto been open and free. Copyrights have been extended time and again, having begun with terms of 14 years, and now thanks to the late Sonny Bono’s famous lobbying for an extension of the copyright term just before Disney’s Mickey Mouse was due to lapse into the public domain, the monopoly for expressions is now the entire lifetime of an author plus an addition 70 years. The public domain, those expressions that are our not only morally but legally to do with as we will, is shrinking by degrees.

The world of free expression must push back against both the tyranny of conformity and the authority of the law. Law that seeks to constrict our free expression must be especially distrusted. Threats to free expression, and the freedom of expressions, come both from attempts to monopolize, and from those who seek to squelch criticism. Expanding notions of libel or slander, reputation and celebrity rights, and other attempts to prohibit the use of that which ought to remain in the public domain, all undermine authors’ moral dignity, and the duty to express. Anything that constrains an author from expressing is suspect. Expressions, except when they are truly libelous (false claims that harm a reputation), are risks for both the author and audience. The author takes the risks described above, that they will succeed and live on unencumbered by the author, or dissipate and die, unknown and unheard. The audience takes a risk that the expressions they consume will change them somehow, and affect them in some deep way that stays with them forever.

The (morally) best authors (and inventors) embrace a radical view of free expression, where they recognize the risks and rewards of creation. God took such a risk, in the Judeo-Christian tradition, creating humanity and giving us “free will.” Because Adam and Eve chose the path offered to them via free will, and consumed of the tree of the knowledge of good and evil, we are here. It was God-as-author’s risk in creating a free expression that humanity would act beyond His control, His command, and become creators too.

Our free will embodies a moral imperative to speak what we believe is the truth, or important, despite the consequences. The corpus of expressions created since the beginning of time are a testament to man’s role as creator, channeling ideas into the world upon which each new generation of creators builds. Who is the author of our culture, or the entire history of human expression? No one person is, but our culture is the sum of all. It is the collective consciousness made manifest in every medium conceivable, told by a litany of voices, creating an orchestra of ideas, a symphony of words, pictures, stories, poems, statues, and science. No greater monument to humanity exists. We cannot bottle it up or create ties binding any one work to any one author.

Homer, Joyce, Yasusda, God, Shakespeare, Johnson, they are all only the genesis, but creation is now beyond their control. Expressions live on their separate lives, unchained and free, evolving and uncredited, and this demonstrates the dignity, duty, and the courage of being a creator. Let us celebrate then the risk of creation, and the duty to let go, the allow our expressions their separate lives, and build a common culture of communication through our evolving media, content that there are expressions -- these supremely human, flawed, and most permanent cultural artifacts. They will survive, like the words on Ozymandias’s fallen statue, which survive even while a culture and its king’s visage lie in dust. They will speak of us long after we are gone, and speak well only if we let them.

Johnson’s book celebrates the unbound word, our Promethean glory as creators free of the debt of credit. His own act of creation, obscured as truths wrapped in fictions, touches upon the duty and ethos of the author and audience, spinning together, weaving something beautiful, and alive, new, and unchained. Somehow and somewhere, beneath or because of the cognizable expressions, imperfectly capturing our ideas, the truth will eventually be known. We are lucky if we get glimpses, and good authors, when they are especially fortunate or particularly talented, may give us those glimpses.

Wednesday, September 26, 2012

ACLU petitions for certiorari to the U.S. Supreme Court.

As predicted, the plaintiffs have petitioned the Supreme Court to review the CAFC decision reported here . The grounds for the petition include the failure of the CAFC to properly apply the decision in Mayo to the facts of the Myriad case. Given the split in the CAFC, and the Supreme Court's own admonition that the CAFC ought to have reconsidered their decision in light of Mayo, it would be highly surprising if they don't decide to take this up next term. Expect more posturing and puffery from those who promote patenting products of nature as the Supreme Court considers the petition and opposing submissions. The fact is, patent attorneys who have made profits by helping corporations to monopolize what cannot justly be monopolized are terrified that the Supreme Court might do the right thing and finally end this practice. I think their fears are justified. A careful reading of Mayo and recent decisions by the Supreme Court on patent matters seems to show a trend against those who contend that one can patent anything simply by drawing artful claims.

Tuesday, July 24, 2012

In Myriad and More, Metaphysics Matters

This past week, the Federal Circuit Court of Appeals heard oral arguments in the AMP v. Myriad "breast cancer genes" case. You'll recall that following its decision in Prometheus v. Mayo, in which, to the shock and horror of patent attorneys everywhere, certain diagnostic methods were considered ineligible for patent under Section 101 as being too close to natural laws or phenomena, the Supreme Court then vacated and remanded the Myriad appeal back to the CAFC for reconsideration in light of Prometheus. The fact that the decision of the CAFC was vacated and remanded, and that the court was asked to reconsider it in light of Prometheus, ought to be a clue that SCOTUS believes that there is some relevance between the two cases, and in fact there is. Both cases have to do with the distinction between the "natural" and the "artificial" or "man-made," as the Chakrabarthy case we have discussed here, and in my book, makes such a distinction for patent eligibility. Namely, "laws of nature, natural phenomena, and abstract ideas" are all explicitly not eligible for patents according to the Supreme Court, even though patent lawyers like to remind us that the Patent Act makes "discoveries" patentable. Sure they are, as long as they are not discoveries of "natural phenomena, laws of nature, or abstract ideas."

This is where lawyers are no longer the most competent experts, though many assume that they are. The distinction between "laws of nature, natural phenomena, and abstract ideas" and everything else is a metaphysical question. Metaphysics and ontology are primarily the expertise of philosophers, not lawyers. So while patent attorneys like to pretend that they are the sole, or at least best arbiters of what ought to be considered patentable, I beg to differ. This is where philosophers are best suited to offer their expertise, because drawing distinctions, applying logic and metaphysics to the world and its objects is in fact what we are trained to do. Lawyers draw distinctions among legal objects, but not sui generis. Rather, they apply precedent and statutes to determine whether objects, acts, or omissions fall into pre-existing legal categories. Their tools are not metaphysical, and when new objects emerge, close analogies, or new statutes are typically necessary to deal with them. But as I have long argued, sometimes the law is ill-suited to solve new problems, or its categories are mistaken from the start on a metaphysical level.

I have never claimed to be an expert in patent law, but as a metaphysician and ontologist, I am a competent critic of its application to the world and its objects. In the case of gene patents, which often include claims over things that are metaphysically best described as "natural" despite their "isolation," courts ought to pay some heed to the underlying categories involved, and what philosophers have to say about them. Philosophers can disagree, of course, and arguments might be made about the boundary between what is natural and what is not, and I look forward to hearing those arguments and engaging with them. But I claim still, as I have all along, that mere isolation of some molecule does not create something "man-made," and I have provided countless examples, including my favorite, isolated O2. Nothing about its structure, even when isolated, is the product of man's design or intention, just as in Prometheus, nothing about the laws governing the interaction of a drug with a person's metabolism is the product of man's design or intention, even if the drug itself was entirely the product of both. The analogies between these two cases are clear, and when one understands the significance of the metaphysics behind Prometheus, it is clear that if the CAFC were to act responsibly and honestly, they would now have to find Myriad's BRAC1 and 2 patents ineligible. But probably we will have to wait for the Supreme Court to do this, just as they did with Prometheus. Or maybe not; hope springs eternal.

Thursday, March 29, 2012

Lies, desperation and the death throes of gene patenting

The recent Prometheus decision has the patent-industrial complex up in arms. The Supreme Court's unanimous decision overturned patents on medical methods that amounted to patents on laws of nature, as I describe more fully in my previous post. One of my old adversaries, Chris Holman, whose incompetent review and attempt to discredit me I refuted here (a refutation he has never acknowledged or challenged), lashed out at me personally, and others (by extension) who disapprove of gene patents, by comparing me with Mike Daisey whose This American Life story on Apple factory conditions was recently retracted. Holman's analogy was faulty, and upon my request he retracted a lie in his post in which he stated that I claimed in Who Owns You? to be "an intellectual property attorney." Because I have never claimed to be so, and certainly not in my book, he retracted his lie upon my request, while explaining that he vaguely recalled it, though he obviously never attempted to verify his recollection by finding the alleged claim in my book. There is of course a certain irony that he had to retract his error (lie) in his own attempt to portray me as a liar. The irony seems to be lost on him, and although his analogy falls apart completely in light of all of the omitted context of my book, as opposed to Daisey's story, which I point out fully in his comments section, his attempt to slur me personally served his purposes anyway. Mainly, proponents of the broadest possible patent regime seek to discredit anyone who opposes them as being "wrong" and "failing to understand the patent system." They wish to be the only experts, and thus the only credible commentators on what can or ought to be patent-eligible. They even suggest that the Supreme Court is unqualified to make law regarding what should be patented. But the Supreme Court in the US is the ultimate arbiter of all US laws, including patent law, having itself created the explicit exceptions to Section 101 patent-eligibility for "laws of nature, natural phenomena, and abstract ideas." Like it or not, the Supreme Court is the final source of authority for what those exceptions encompass, not patent lawyers or even the Federal Circuit.

So the patent-industrial complex, which always profits from the mere act of patenting (by fees on filing patents, costly patent-law seminars, etc.), and which thus seeks to keep as broad as possible the domain of patent-eligibility, is struck with fear and trembling. They are looking to blame those of us who are not part of the system, who have no economic stake in the patent system, and who seek only to preserve the scientific commons against monopolization, and accuse us of meddling in their realm. As I have argued all along, the law is open to debate, and subject to change, and in the case of gene patenting I believe it ought to be changed because it neither reflects the spirit of the purpose of patent law, nor logic itself. The Supreme Court seems to agree, and has altered the law. The Court of Appeals, Federal Circuit (CAFC) has been overturned. Its decision in Prometheus was completely overruled, and the types of method patents at issue in that case are no longer to be tolerated. That is the law of the land. Moreover, it vacated and remanded the CAFC's opinion in the Myriad case about the BRCA 1 and 2 patents. This bodes ill for gene patent proponents, despite their attempts to try to distinguish the two cases. In fact, the Prometheus decision's reasoning makes the Myriad product patents even more questionable than those at issue in Prometheus, which at least involved "methods" in which the laws of nature monopolized were couched. Four of the claims challenged in the Myriad case are claims over merely "isolated," unmodified gene sequences with no method or process involved.

The CAFC panel on Prometheus which was overturned unanimously by the Supreme Court unanimously approved of the now invalid patents. The CAFC panel in the Myriad case was not unanimous. As I explained last year, some of the method claims at issue in Myriad were already struck down, and there was a dissenting opinion by one of the three panel members, Judge Bryson, who wrote that the product claims at issue were also invalid as products of nature. It is unlikely that Bryson will change his mind, and it is unlikely that Judge Lourie will change his mind (the Myriad court consisted of Lourie, Bryson, and Moore, the Prometheus court was Lourie, Rader, and Bryson). The wild card is Judge Moore. Will Bryson convince Moore, who filed a concurrence in the Myriad case and who did not sit on the overturned Prometheus appeal, that she ought not to stubbornly side with the losers as Rader did in the Prometheus case? Justice Breyer's decision gives plenty of ammunition to Moore and Bryson to write a majority opinion overturning the Myriad patents as amounting to claims over products of nature. In any case, whatever the CAFC decides to do, there will again be a petition for certiorari to the Supreme Court. If the CAFC does the right thing and reverses its previous decision in light of the Prometheus decision, then the Supreme Court is unlikely to take it up on cert, feeling that their Prometheus reasoning is correctly applied to overturning Myriad. If the CAFC decides to try to weasel around the Prometheus ruling it will still be a split panel, and SCOTUS would likely hear the Myriad appeal eventually. The CAFC may wish to write a narrow ruling overturning the Myriad patents, but leaving the door open enough for similar patents, and avoiding the sort of broad restriction that the Supreme Court could craft. Or they may decide to do what they did before and drop kick it to SCOTUS for some final ruling. Patent attorneys who are thinking far enough into the future ought to hope that the CAFC overturns their previous Myriad reasoning on some sort of narrow grounds, invalidates the Myriad patents and leaves the door open somehow for other sorts of gene patents (like those on cDNA), rather than allow this to finally be determined by the Supreme Court which seems hostile in general to the rhetorical cuteness of claim-drafters.

In the meantime, expect the rhetoric and public wailing to swell in an effort to influence the public's perception of what horrible fate might befall us all if patent attorneys cannot patent everything under the sun, and what the hell, why not the sun itself? I and others who oppose gene patents have withstood a lot of public abuse, but the reasoning we have employed has survived, and so far is winning the day. The law of the Myriad case is now the district court's decision, until the CAFC issues a new one, and that means the Myriad gene patents are invalid, for now. Let's see what happens next. In the long arc of history, I do believe that justice ultimately prevails.

Saturday, July 30, 2011

Myriad case, Federal Circuit decision - reason for hope

No one can be terribly surprised that the Federal Circuit ruled essentially to continue the practice of gene patents yesterday. But there are some surprising tidbits in the various, lengthy, and somewhat contrary decisions of the three panel judges. One disappointment for gene patent proponents was the ruling on standing, which held that indeed there was standing for the plaintiffs to bring a declaratory judgment action as they did. Some hoped that the Federal Circuit would drop-kick the case on standing and never have to reach the substantive issues. Those hopes were dashed when the court concluded that there was at least one plaintiff with standing to sue based on an ongoing harm.

More surprising is the holding regarding the method claims relating to comparing or analyzing sequences, which the court struck down unanimously as unpatentable under Bilski. This is a minor win, and increases the likelihood of continued appeals as no-doubt Myriad will want to have either the en banc circuit review this, or the Supreme Court (perhaps both will happen eventually).

Unsurprising is that the court ultimately upheld their reasoning that X sometimes does not equal X. Violating the logical law of identity has been the underlying reasoning behind such ridiculous decisions as Parke-Davis (cited by the court) which established the "isolated and purified" notion by which a number of patent attorneys now are forced to argue that sometimes two morphologically identical molecules are nonetheless not identical. In continuing to strain logic, the majority decision holds that the sequence claims cover patent-eligible compositions of matter. But the silver lining is that there is division on the court, and the reasoning of the Majority, and concurrence of judge Moore, illustrate just how strained the logic has become. Moore argues that there is some significant chemical distinction between an isolated gene and a gene found in nature because at the ends of the isolated gene are nothing, whereas at the ends of the gene found in nature are more nucleotides. This does not support any claim of morphological difference between the claimed gene or gene parts and the sequence identified as occurring in nature. As I argue in my book, drawing a border does not create, automatically, a new, unique thing, especially where, as here, the information encoded in the string (which directs the functionality of a gene) is nature's own definition of a border.

Finally, Judge Bryson sees clearly the illogic of extending patent eligibility to isolated DNA, and writes a dissent to that part of the majority holding, using arguments I and others have made often.

What this means is surely that this fight is far from over, that it will be appealed, likely, to the en banc Federal Circuit and ultimately to the Supreme Court. Unfortunately, by the time a Supreme Court decision is final, Myriad will have run out the clock, having reaped its billions in profit from their unethical practice before the patent expires.

Wednesday, August 4, 2010

Open Science and Economics

The Open Science Summit (here are my slides) has concluded, and it marks the start of a very important ongoing conversation, including discussions we should continue to have about the practical effects of patents on innovation. My arguments have always been both theoretical and practical. While Ron Bailey at Reason relates "Numerous studies have so far failed to find that gene patents are a big impediment to either research or innovation" in reporting on our session at the Summit, there are also numerous such studies showing that the impact is in fact bigger than some make it out to be. One noteworthy recent addition to the empirical evidence is this article, by Heidi Williams of Harvard University - Department of Economics; National Bureau of Economic Research (NBER), entitled "Intellectual Property Rights and Innovation: Evidence from the Human Genome" which just came out this past month. She sent me the following link, and below I summarize and provide some useful quotes:

Williams tracks the progress of individual discoveries, looking at the research that was conducted on both patented and unpatented genes, and comparing the rate of innovation and commercialization resulting from both. she states, in describing her methodology: "My empirical analysis relies on a newly-constructed data set that traces out the distribution of Celera's IP across the human genome over time, linked to gene-level measures of scientific research and product development outcomes." ... significantly, she finds:

"For each gene, I collect data on publications investigating potential genotype phenotype links, on successfully generated scientific knowledge about genotype-phenotype links, and on the development of gene- based diagnostic tests that are available to consumers. Both the cross-section and panel specifications suggest Celera's IP led to economically and statistically significant reductions in subsequent scientific research and product development outcomes. Celera genes have had 35 percent fewer publications since 2001 (relative to a mean of 1 publication per gene)."

finally, she concludes:

"I estimate a 16 percentage point reduction in the probability of a gene having a known but scientifically uncertain genotype-phenotype link (relative to a mean of 30 percent), and a 2 percentage point reduction in the probability of a gene having a known and scientifically certain genotype-phenotype link (relative to a mean of 4 percent). In terms of product development, Celera genes are 1.5 percentage points less likely to be used in a currently available genetic test (relative to a mean of 3 percent). The panel estimates suggest similarly-sized reductions, on the order of 30 percent. Taken together, these results suggest Celera's short-term IP had persistent negative effects on subsequent innovation relative to a counterfactual of Celera genes having always been in the public domain. The panel estimates measure a transitory effect of Celera's IP, and suggest that innovation on Celera genes increased after Celera's IP was removed. However, the cross-section estimates measure more persistent e ffects and suggest that Celera genes have not 'caught up'"

The evidence is growing more damning all the time. This study cites the Murray study I have previously cited here, and nails the lid in the coffin, as far as I can tell, on the economic effects of gene patents. I hope you'll read this paper. I am thankful that economists like Williams are continuing to blow the lid on the real story of patents, and how they inhibit both science and commerce.

Thursday, April 1, 2010

Two brief media hits

An op-ed co-authored with Ken Alfano in the Washington Times today, and a radio interview this morning on The Takeaway, out of WNYC, syndicated nationally in the US. A couple more, potentially big, are in the works. I did a lengthy pre-interview yesterday with a US national network. The good news is that this decision got the media to finally pay some attention to this issue, and the momentum is now with our side of the story. I cannot praise enough those with both the ACLU and Public Patent Foundation for bringing this lawsuit, and calling much needed attention to the problem of gene patents. More to come...

**UPDATE** Here's an excellent piece from Forbes explaining why the technology of cheap sequencing, and the potentially profitable and beneficial services that could be offered, demand that gene patents cease.

**UPDATE 2** so, apparently Joseph Priestley could have (or could not have) patented O2. Read through all the comments to see a truly Alice in Wonderland chain of reasoning.

Wednesday, March 31, 2010

Win!

I must remember to take more holidays. Everything truly interesting seems to happen when I'm far from my computer. Of course, the ACLU's suit against Myriad is the big news, with proponents of gene patenting scrambling to find fault, or predicting armageddon as the result of Judge Sweet's well-crafted decision. Essentially, the judge held, as I have argued here and in my book, that the patents granted on gene sequences cover products of nature, which are otherwise not eligible for patent protection. He saw past the cute, lawyerly tricks that have been used to try to argue that "isolation and purification" of a gene result in something, somehow unique, and he found as reason and logic dictate: nature made the patented sequences at issue in the case, not man, and the patents are invalid under Section 101. See also my post "It's the novelty."

Expect a long, hard slog as this case moves up to the Federal Circuit Court of Appeals, and then, obviously, to the Supreme Court. Meanwhile, we may get a clue as to SCOTUS's leanings when they issue a decision in Bilski.

Tuesday, March 30, 2010

WOW

...on holiday at the moment, and this keyboard is too odd to do a detailed post, but suffice it to say for the moment that I am stunned and thrilled that the District Court ruled against Myriad! Much more soon!

Thursday, March 4, 2010

Commons Sense

One of my recurring frustrations in making my case against gene patents is the failure by some to grasp the argument I am trying to make regarding the nature of "the commons". Perhaps I have been unclear, or maybe the approach I am taking to property law and justice is too far afield from those more frequently made to be immediately understood. Yesterday, however, I gave a guest lecture in an ethics course for ICT students (software programmers, mostly), and gained a lot from the experience. These students not only grasped the argument, but embraced it, and helped to clarify a subtlety that I need to elaborate upon in defining the "commons by necessity" that I believe genes and other parts of the universe belong to.

Briefly, to summarize, I argue that the justice of property rights derives from the logical and practical ability of people to enclose a space, and the need for a rival to use violence to dispossess a possessor of the space. Thus, property rights in land and movables are grounded in these brute facts. There is no such grounding for intellectual property rights. Moreover, there are parts of the universe that cannot be justly owned, and IP claims over these "commons by necessity" are unjust. These are parts of the universe which cannot be held exclusively by anyone, as a matter of brute fact. Examples include: the laws of nature, radio spectra, and genes which are de facto unencloseable. My thanks to Stephan Kinsella who helped me to realize that this applies, actually, to all ideas, and thus makes all IP law a similar incursion on an unencloseable commons by necessity.

My thanks go to some of the students yesterday who pointed out a fine distinction in the realm of objects belonging to the commons by necessity (as opposed to the commons by choice, which includes encloseable spaces over which we make choices to maintain no private ownership). They pointed out that there are commons not just by logical necessity like radio spectra and laws of nature, but also those that might be called commons by practical necessity which includes sunlight. So one could, given enough time and technical capabilities, enclose the sun and harness its power monopolistically, but this is a very remote technical possibility.

Genes, I argue, are logically unencloseable, and thus clearly belong to the commons by necessity, and attempts to give monopolistic control over them are per se unethical. If there's only one point I hope readers take away from my book, this is it.

**update: I just learned Who Owns You? is being translated into Portuguese! My first book came out in Japanese and Portuguese, so maybe Japan will soon follow suit. I'll keep you updated.


Wednesday, January 13, 2010

LA Times hits the nail on the head

Echoing many of my own sentiments, this editorial in the LA Times gets it right. The patents involved cover naturally-occurring entities, not artifacts, and as such fall squarely outside of what ought to be considered patentable subject matter. I have drafted an editorial of my own which I am shopping around, trying to focus the debate on this crucial issue, and clear up the purposeful confusion generated by pro-gene patent attorneys. As usual, Kevin Noonan over at Patent Docs disparages the editorial authors for getting everything wrong and not understanding patent law. This is the typical line. We understand it completely, just not the way you want us to do so, Kevin. Your interpretation strains logic, and reason, and protects your clients and your vested interests, but the public is beginning to see through this charade, and challenge the status-quo. Let's hope the judge does too.

Wednesday, December 9, 2009

The Perils of Pure Positivism

The dominant paradigm among law schools training young students to be lawyers is to indoctrinate them into accepting the truth of legal positivism. This trend continues the once fashionable school of Critical Legal Theory (in which law is politics, pure and simple), which went out of fashion, at least as a term, with the collapse of the allegedly Marxist states. In "pure" legal positivism, there is a complete disconnect between law and morality, and the validity of enactments derives from the fact of their enactment (to simplify greatly). In law school, I too read Austin and Hart, and modern proponents like Dworkin, I just never bought them. Legal positivism is the legal equivalent of moral relativism, and leaves open the door to too many hypothetical conditions under which we would be forced to accept the justice of clearly unjust enactments. As a believer in Justice, I maintained my allegiance to the classical, liberal underpinnings of the US Constitution, grounded as it is in a form of natural law theory.

Yet, in the current debate over gene patents, I can see that the grip of legal positivism on lawyers, especially patent attorneys it seems, is tenacious. As I have argued, intellectual property is not derived from natural law, and is thus a set of purely positive enactments. If there were no conflicts with natural law, then all its enactments would be "just," or at least acceptable. It is clear that a number of patent attorneys arguing for the continuation of gene patents either see no truth to natural law theory at all, or cannot grasp the necessity that positive enactments may not justly contradict natural law. It seems most likely, from my recent debates with gene patent proponents, that embracing pure legal positivism is a convenient way in general for lawyers to avoid cognitive dissonance, as there is never the threat that one might have to defend a stance that is, by nature, unjust.

And so, my continuing call to recognize that law must be naturally constrained from granting ownership to things that, by nature, cannot be exclusively possessed, that belong to what I term a "commons by necessity" continues to be misconstrued as a utilitarian call to recognize common rights for some other purpose. Rather, it is a recognition of a simple, necessary law of being, much like that which requires 2+2 to equal 4. Some things, like natural laws, cannot be possessed to the exclusion of anyone. Naturally occurring genes fall into this category too, as a matter of natural law. Positivists who fail to grasp this, or who refuse to recognize this, are persuaded that this is but a matter of choice. To them, I would ask, have you forgotten your Orwell?

"In a time of universal deceit - telling the truth is a revolutionary act."

— George Orwell


Monday, November 9, 2009

Stop Lying about the Myriad Patents on BRCA 1 and 2

Numerous defenders of Myriad often claim that the patents do not cover naturally-occurring genes, but rather only "methods" created by humans, or "isolated and purified" genes, which they allege can only be created by man. After all, they claim, isolated genes do not appear in nature, and it takes the work of humans to create them. This is, of course, hogwash. Isolating a gene is accomplished in nature in the process of cellular metabolism. Protein synthesis is accomplished without human intervention, much less, human invention, because various forms of RNA read the beginnings and ends of genes, omit the introns, and construct proteins from the remaining (exon) codons. So, merely finding the beginning and end of a gene is, as I have analogized in my book and elsewhere, equivalent to reading a map, and noting a geographical feature therein. Nature made the feature, and defined its borders, and we simply find it and model it. So that's the "isolation" and it doesn't warrant patent.

The "purification" part is part of nature's bag of tricks too, as mRNA skips the introns (the non-protein coding regions), and in fact some laboratory methods for creating cDNA (thus "purifying" DNA) use mRNA to accomplish this. Again, nothing at all inventive.

Finally, the Myriad patents on BRCA1 and 2 claim un-modified genes -- mutations in the BRCA1 and 2 gene that occur naturally. Their sole inventive claim is "isolation." See the patent yourself, and look at the claims (pp. 153-156). Look specifically at this:

"1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.

5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2."


Now, note: these are not method claims, they are not claims for cDNA, but rather over naturally-occurring mutations to naturally-occurring genes. As I discuss above, and in my book, and elsewhere in this blog, this is not inventive at all. Rewarding for discovery of laws of nature goes beyond the scope of patent, and it inhibits research, and access to the "commons by necessity" that is the human genome and laws of nature in general.

It is like saying that since detached bird wings do not exist in nature, one ought to be able to patent detached bird wings. It's madness, and everyone except patent lawyers and others getting wealthy off this insanity can see that.

Tuesday, November 3, 2009

Good News from the District Court

Judge Sweet did the right thing on the defendants' motions to dismiss, refusing to grant those motions, and ensuring this case can go forward on the merits. This is excellent news, and a sound rejoinder to the insistence by the likes of Holman, Noonan, Quinn, and other pro-gene-patent folks that this case was "frivolous." For non-lawyers, the claim of "frivolous" is particularly charged given that, in federal court, a lawyer can be sanctioned for bringing a frivolous claim. Moreover, in federal court, the pleading requirements for a claim are rather liberal, and as long as the claim is colorable, involves some real, federal case or controversy, and plaintiffs have suffered some injury which the court can redress, then the complaint is not frivolous.

I am still reading the decision, but it indicates that the court is certainly aware of the importance of this case, and the necessity of resolving the claims in federal court. Much depends upon it. I am thrilled about this decision since it means the merits will be resolved one way or another. The summary judgment motion is now pending, and has been fully briefed. Now we shall see how the court decides that motion, which would go to the merits of the claims, and then watch this baby go on up to appeal... eventually, to SCOTUS.

Thursday, October 29, 2009

Doing Philosophy in Public

Lately, I feel that the ivory tower is crumbling. Or at least it is developing some stress fractures. This is a good thing. For too long, the academic world and the real world have been at odds. Academics, intent on fulfilling the career goals, and standardized path of academic achievement, have helped to perpetuate the lay-public's view that academics are isolated, uninvolved, and mostly irrelevant. Academic disputes might be heated, emotionally charged, and the may make or break academic careers, but rarely do these disputes matter to the world at large. As the link above notes, Henry Kissinger correctly noted that the bitterness of academic disputes "is in inverse proportion to the importance of the subject." Indeed, among academics the currency of the trade has often been to find an opponent, attack, and if possible, destroy. But does any of this intellectual parrying matter to anyone, and must this be the future model of the academy -- to provide a sort of Punch and Judy show as occasional tidbits to a bemused public already wary of the goings-on in university halls? Simply put, no. It doesn't need to be like that.

Sometimes, we can step outside this model, seek not only positive collaborations between the academy and the "real" world, but also work to make ourselves relevant to the public in broader ways. This is part of the virtue of applied ethics, and one reason I have been thrilled to be at TU Delft. Here, engagement in the world is part of the goal. Applied ethics means nothing without a world to apply it to, and projects and researchers working on applied ethics in the Dutch technical universities are not only training engineers to think ethically, but also engaged in projects involving policies affecting hundreds of thousands of people. This is as it should be. Never before have I felt more at home in striving for public policy changes based upon my research. Where once my goals to take my research and do something with it might have been met with scorn by entrenched academic establishments, I am now encouraged by an atmosphere that accepts and even embraces the next logical step: change.

Three years ago, when I began to approach the issue of gene patenting, it was more or less just an academic question to me. Yes I felt viscerally that this was an important issue, but I never realized the extent to which it impacted the lives of hundreds of thousands of people around the world (if not more), or the extent to which others were moved to finally act on the issue. When, two months after my book came out, the ACLU sued Myriad on this very issue, and now with the US dept of Health and Human Services making some progress in suggesting significantly altering gene patenting, I can see that applied ethics must naturally reach out as an academic field into the real world of activism.

I had the great fortune last week to be where the rubber meets the road on this issue, in what could legitimately be called "gene patent week" in New York City. There, I met with the attorneys for the ACLU, as well as a patent attorney who has been a harsh critic of my work, calling me, the ACLU, and other opponents of gene patenting "liars"(though, even now, he admits not having read my book). I met with Luigi Palombi, whose book Gene Cartels came out just recently, and does for the legal case against gene patents what mine does for the ethical case. I met the director of the film "In The Family," Joanna Rudnick, who possesses the BRCA1 mutation that makes her susceptible to breast and ovarian cancer, and who discovered in documenting her experiences that the patent that Myriad Genetics owns for that gene prevents her and many others from accessing information about their own bodies, from getting second opinions about her tests, and for many women, the prohibitive price of the test prevents even getting the test done in the first place. I met clinicians and researchers, like Debra Leonard and Ellen Matloff, each of whom has personal experience with how gene patents prevent doctors, researchers, and patients from getting access to information that is not only vitally needed, but part of nature, a natural law, and thus not properly owned. I met with Tania Simoncelli and Sandra Park, of the ACLU, who have striven each in her own way to actually end the process of gene patenting. Tania's background is in science, and she has fought for years to get a suit started, and Sandra is an attorney who is fighting valiantly in the courts. I met Dan Ravicher and Chris Hansen, of the Public Patent Foundation and the ACLU, each of whom has staked his organization's reputations on bringing this courageous and necessary suit.

These people humbled me. What began for me as an academic issue is now personal, and a matter of activism. This is not academia, and the rhetoric around the edges of the debate, the name calling, insinuation, and arguing about the meanings of terms and legal rulings must be put into perspective. People are being hurt, and these harms are not academic. They are wrong. Public policy must change. Never before has it been clearer to me that this is not just an issue for debate, but the cusp of something big.

I had the great fortune to meet and interview James Watson, co-discoverer of the structure of DNA, and I asked him about gene patenting. He opposes it, and he says his opposition was why he was "fired" from the Human Genome Project. He stated in our 45 minute on-camera interview that "something has to give" and that gene patenting cannot continue. It is harming too many people. I value his judgment as a scientist, and his concern as a person came through when he expressed his disdain for the costs associated with a non-inventive test that has been given an exclusive monopoly through patent.

I particularly value the energy, commitment, and involvement of academics, lawyers, clinicians, and counselors -- all those named above and many more unmentioned, who have moved beyond the academic issues involved and sought to change the world because they know that their cause is just. They have staked their reputations, their careers, money, relationships, and futures on pursuing this change, and their commitment should embolden us all. It gives me strength, and makes me thankful that here, applied philosophy means involvement in the world, unashamedly pursuing the good, and making philosophy relevant once again.

Friday, October 23, 2009

That was the Week that Was

I have hope. And I have evidence now that hope is worthwhile. This week has been nothing short of amazing. Somehow, everything seems to be happening at once, and now I feel as though the prospects for action to stop gene patenting are good. There is clear momentum, and public support, and a growing group of disparate activists and academics who have somehow begun to convene. In sum, here's what has happened this week:

Monday: I met with Luigi Palombi (see previous posts) and things are in the works now to take this movement international, with real backing and strength. We then attended a screening of Joanna Rudnick's film "In The Family" at Cardozo Law School, and met Dan Ravicher of the Public Patent Foundation. I also met Kevin Noonan, who was the lone voice on the other side of the issue, and who is a some-time foil, having critiqued my book (before reading it) on his website -- Patentdocs. He was a gentleman, though, and I hope he'll take part in our film and offer the reasoning behind gene patents.

Tuesday: Taylor Roesch and I interviewed James Watson for our documentary. He delivered some extraordinary sound bites in opposition to gene patenting, and provides unparalleled scientific credibility on the subject given his connection with the human genome's discovery and mapping. Later that evening, we went to another screening of "In The Family" at the Tribeca Cinema, where we were able to film a panel discussion on the legal implications of gene patenting and the ACLU vs. Myriad lawsuit.

Wednesday: I gave my talk at Cardozo Law School, entitled "The Ethical Case Against IP," which we also filmed for the movie. We then went to Harlem where we filmed an excellent interview with Luigi.

Thursday (today): Taylor interviewed me for the documentary. We shot in Central Park, which was brilliant, crisp, and sunny, and the leaves are beginning to turn. It was good to be in the park, even if we were working. I then headed downtown and did a live interview on the Leonard Lopate Show. There's a link to the interview (and all similar press) from my homepage, under "press."

Tomorrow and Monday: I have a call-in interview for WBAI Evening News, and then, perhaps, a moment to breathe. Then Monday, I will debate Gene Quinn on the issue of patents and innovation, and then tape an interview with Laura Flanders of Grit TV.

*UPDATE* here's the GritTV spot, I think it went very nicely.

In sum, the ACLU lawsuit, Luigi's activism in Australia and elsewhere, the recent HHS draft report, and the public's overwhelming support of the movement to eradicate gene patents (when they learn it is happening) give me courage, hope, and strength to continue this work, and seek real and lasting change.

Friday, October 9, 2009

Great report from US-DHHS

So, it seems that the US Dept. of Health and Human Services will recommend de-fanging almost completely gene patents as they are presently granted in the US. Essentially, they have reached the same conclusions that I reach in my book regarding the nature and utility of gene patents and effects in creating patent thickets. Because the report is not available yet, I cannot say whether they address any of the ethical issues involved. Here's part of the conclusion reported at IPWatchdog, where my friend Gene Quinn is naturally quite alarmed by what I consider to be a fantastic step forward:

"For the most part, patents covering genetic tests and related licensing practices do not appear to be causing wide or lasting barriers to patient access. However, the case studies and public comments documented several situations in which patient access to genetic tests has been impeded for segments of the population—especially indigent patients—when these tests are offered by an exclusive provider or a limited number of providers, a practice directly enabled by current patenting and licensing practices."

I look forward to reading the final report and hoping that Congress acts as recommended.

Saturday, August 22, 2009

A methodical response to Chris Holman's "review"

I will work through as many of his specific citations of error. In general, his allegations of error rely on one disregarding the context of my policy and logical discussion of the law, which includes my dismissal through argument of many of the current law’s assumptions (such as that “isolation and purification” somehow turns a gene into something “new). In re-reading my book in light of Holman's review, I kept thinking maybe he and I read a different book, there's so much he disregards and so little he focuses on. But here are my responses to as many of the alleged errors as possible:

1.) I caught most of my discussions of nucleotides in proofing, but did apparently miss some cases in which I refer to a nucleotide or nucleic acid as an amino acid. mea culpa

2.) My discussion of introns is accurate though not in-depth, but Holman doesn’t specify how I allegedly erred.

3.) Patent law does apply to discoveries, but they must be “new.” Now, this does not include discoveries of natural things that have long existed, which are not “new” and the case law is clear on this. The only “discoveries” that can then be logically patentable are those that are somehow inventive, which I argue genes are not, even in their “isolated and purified” state. Once again, this is an instance of Holman taking the conclusion of an argument I make out of the context of the argument itself, claiming it is an error rather than explaining the line of reasoning that leads me to my conclusion, and then saying I am merely wrong. We disagree, and I state my reasons in the book.

4.) As I state in the book, US patents do effect other jurisdictions thanks to the WTO and TRIPS agreements. Europe and Japan do not allow “gene patents” on unmodified genes, specifically, they disallow patents over the sequences, although they allow patents on genes used in some new process or product involving an “inventive step,” which helped, for a time, prevent the BRCA1 and 2 patents in Europe, though they are now allowed (to a degree). I argue that new products incorporating laws of nature or natural parts are patentable as a whole. The BRCA1 and 2 patents allowed in Europe are closer to what I would consider to be proper, though I have ethical issues with them as well. This is a point made in The American Interest article as well.

5.) I argue in my book that the yeast and adrenaline patents were erroneous. The adrenaline patent, if it protected the compound adrenaline, could not have protected its naturally-occurring analogue, so what more could it have logically protected other than the process of synthesis? I think I could have done a better job making this logical dispute with those patents explicit. An analogy would be water. If one developed “isolated and purified” water, synthesized it from scratch, and patented it, then in what logical sense could it also protect the molecule H2O? It couldn’t, so it would only be a process patent, no matter what the claims state. As for a patent on a representation of a gene, this was presented as a hypothetical that would accord with my overall theory of IP law, and not as an example of how patents are actually issued. My general theory of intellectual property states that all man-made expressions, intentionally-produced are potentially protectable, in which case so would representations of genes be protectable. Except, I conclude in the case of existing genes that they belong to a commons by necessity which can never be enclosed.

6.) I do discuss Moore at length, I do point out it is a state case, and put it in the historical context that helped convince Celera’s attorneys to begin patenting genes. It is a well-known, historically important case in the development of the law regarding ownership issues in products of human tissues. I put it in that context explicitly in the book.

7.) Patents do include a right to enjoin, I don’t see that leaving that out is a "serious misstatement" about patent rights, which I do mention include the rights to royalties and fees. In fact, the injunction right makes gene patents worse, so thanks to Holman for mentioning this as well. US patents have extra-jurisdictional effect, as mentioned before, through WTO and TRIPS. As I argue, US IP law has a powerful influence on other jurisdictions.

8.) The next long criticism relies on buying Holman’s and other patent attorneys' argument that “isolation and purification” creates something new, which I argue at length in the book it does not. Thus his conclusion “All of these scenarios would indeed raise serious ethical concerns if they had any basis in reality, but in fact all are mere figments of the author's imagination resulting from his profound misunderstanding of patent law,” does not take into account my lengthy argument about isolation and purification, and all the scenarios I mention are thus technically true (under my interpretation of the logic involved), and not at all fiction. What Holman calls a “misunderstanding” of patent law is part of my central disagreement over the scope and effect of gene patents (not a misunderstanding) because of my arguments about the ontological status of genes, both “isolated and purified” and otherwise. This point is crucial to an understanding of my ethical arguments which he completely misses as a result.

9.) I have referenced Murray’s studies about the chilling effect of gene patents. There is certainly room for dispute, and more evidence is needed. Ultimately, my conclusion is based on the ethics, not the practical effect.

10.) I do summarize arguments made by others and cite to as many as I had considered, but I also break new ground which Holman ignores or possibly misses. For instance, his characterization and dismissal of my central argument in Chapter 7, which he calls a rehash of the anti-commons arguments of others. It is not, I don't even use the term "anticommons," and no one who has actually read the chapter could conclude that it relates in any way to any anticommons argument at all (which is a utilitarian argument, while mine is not). That chapter makes the ontological argument which supports my ethical conclusion, regarding the existence of certain things which I call “commons by necessity” and which I conclude DNA belongs to.

11.) The rest of the review basically defends the practice of gene patenting, making this more clearly an advocacy piece, and less a book review.

All told, Holman’s review focuses on about 10 pages of my book, in which I discuss law and cases, and leaves out the bulk of it. In writing this response, I went back and carefully re-read my book and was amazed at just how much of my discussion is completely ignored, and how little of what I write about is actually referenced. It seems that those who disagree with my conclusions have done their best to turn points of contention and disagreement over policy into allegations of “error” where in fact, there is plenty of argument to be made on either side. My book makes one argument, but let’s not pretend that the arguments on the other side are “fact” when they are simply arguments which I have taken care to dispute in making my own.


http://www.typepad.com/services/trackback/6a00d8341c659b53ef0120a55f3734970c